FDA applicant
Takagi Seiko Co., Ltd.
FDA records 5 decisions for Takagi Seiko Co., Ltd. (Nakano-Shi, JP) from 2007 to 2018: 5 510(k) clearances. Most are in product codes HJO (Biomicroscope, Slit-Lamp, Ac-Powered) and HKY (Tonometer, Manual). Since 2016 its 510(k)s took a median of 205 days from receipt to decision, against 232 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Takagi Seiko Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Takagi Seiko Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report